Laparoscopic Transabdominal Cerclage: New Approach

March 22, 2017 updated by: Ahmed Maged

Laparoscopic Transabdominal Cerclage: A New Ideal Approach

A 5-mm non-absorbable Mersilene polyester suture, with adjacent partially straightened blunt needles, is introduced into the abdominal cavity through the 5-mm trocar. However, flattening the curvature of the needles, while introducing the tape into the abdomen, will eventually pose a challenge during placement of the stitch (the needles' curvatures guarantee that the tissue penetration is done away from the uterine vessels).

To overcome this problem, the following method was devised. A one cm suprapubic incision is made on the abdomen with a scalpel short of the peritoneum. A needle holder loaded with the needle is pushed through the incision until the tip is seen inside the peritoneal cavity. A grasper from one of the flank ports receives the tip and the needle is delivered carefully (FIGURE 1). The rest of the tape is pulled until the blunt end of the other needle appears, to be delivered in the same way but in the reverse order.

• Operative Steps The vesico-uterine peritoneum is opened using scissors & the urinary bladder is dissected downwards from the lower uterine segment to expose the uterine vessels anteriorly on both sides . Both needles are passed through the lower uterine tissue medial to uterine vessels on the right & left sides (from anterior to posterior) . Then, both needles are passed through the remaining cervical tissue medial to uterosacral ligaments towards the posterior vaginal fornix (on the right & left sides) guided by laparoscopic illumination . When the needles' blunt ends pierce the vaginal vault, the assistant pull them through the posterior vaginal fornix . After trimming of both needles, the Mersilene tape is tied tightly behind the intravaginal segment of the cervix with five knots & the ends of the stitch are trimmed. The vesico-uterine peritoneum is then reapproximated over the laparoscopic cerclage with a running (00) Monocryl suture that is tied intracorporeally.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Under general anaesthesia, the patient is placed in the modified dorsal lithotomy position. The patient is then prepped and draped in the usual fashion for an abdominal & vaginal procedure. A vaginal speculum is inserted into the vagina to expose both the cervix and posterior fornix. A uterine manipulator is inserted in the uterus in non-pregnant patients, followed by placement of a Foley's catheter in the bladder. As regards port placement, a 10-mm umbilical trocar & two 5-mm trocars in right & left lower quadrants are inserted.

• Introduction of Mersilene Tape into the Abdominal Cavity: A 5-mm non-absorbable Mersilene polyester suture, with adjacent partially straightened blunt needles, is introduced into the abdominal cavity through the 5-mm trocar. However, flattening the curvature of the needles, while introducing the tape into the abdomen, will eventually pose a challenge during placement of the stitch (the needles' curvatures guarantee that the tissue penetration is done away from the uterine vessels).

To overcome this problem, the following method was devised. A one cm suprapubic incision is made on the abdomen with a scalpel short of the peritoneum. A needle holder loaded with the needle is pushed through the incision until the tip is seen inside the peritoneal cavity. A grasper from one of the flank ports receives the tip and the needle is delivered carefully . The rest of the tape is pulled until the blunt end of the other needle appears, to be delivered in the same way but in the reverse order.

• Operative Steps The vesico-uterine peritoneum is opened using scissors & the urinary bladder is dissected downwards from the lower uterine segment to expose the uterine vessels anteriorly on both sides . Both needles are passed through the lower uterine tissue medial to uterine vessels on the right & left sides (from anterior to posterior) Then, both needles are passed through the remaining cervical tissue medial to uterosacral ligaments towards the posterior vaginal fornix (on the right & left sides) guided by laparoscopic illumination . When the needles' blunt ends pierce the vaginal vault, the assistant pull them through the posterior vaginal fornix . After trimming of both needles, the Mersilene tape is tied tightly behind the intravaginal segment of the cervix with five knots & the ends of the stitch are trimmed. The vesico-uterine peritoneum is then reapproximated over the laparoscopic cerclage with a running (00) Monocryl suture that is tied intracorporeally.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
15

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 12151
        • Kasr Alainy Medical School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 41 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Failed vaginal cerclage 2 successive spontaneous mid trimesteric abortion

Exclusion Criteria:

  • rupture of membranes Uterine contractions evidence of intraamniotic infections contraindications to laparoscopy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Laparoscopic cerclage
The vesico-uterine peritoneum is opened & the urinary bladder is dissected downwards . Both needles are passed through the lower uterine tissue medial to uterine vessels on the right & left sides . Then, both needles are passed through the remaining cervical tissue medial to uterosacral ligaments towards the posterior vaginal fornix (on the right & left sides) guided by laparoscopic illumination . When the needles' blunt ends pierce the vaginal vault, the assistant pull them through the posterior vaginal fornix . After trimming of both needles, the Mersilene tape is tied tightly behind the intravaginal segment of the cervix with five knots &
Procedure: laparoscopic cerclage
The vesico-uterine peritoneum is opened & the urinary bladder is dissected downwards . Both needles are passed through the lower uterine tissue medial to uterine vessels on the right & left sides . Then, both needles are passed through the remaining cervical tissue medial to uterosacral ligaments towards the posterior vaginal fornix (on the right & left sides) guided by laparoscopic illumination . When the needles' blunt ends pierce the vaginal vault, the assistant pull them through the posterior vaginal fornix . After trimming of both needles, the Mersilene tape is tied tightly behind the intravaginal segment of the cervix with five knots &

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
completing pregnancy
Time Frame: 36 weeks of gestation
number of participants with completing pregnancy
36 weeks of gestation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ahmed Maged

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2004

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2016

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 25, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 27, 2015

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 29, 2015

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 24, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 22, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 136

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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